Alcon LADARVision 6000 CustomCornea Recall

The CustomCornea software algorithm installed in the Alcon excimer lasers commonly used for LASIK vision correction surgery have been recalled by the FDA after a marginally high percentage of serious complications in patients of the laser vision correction procedure. The laser was designed to reshape the cornea during LASIK surgery with the intent of eliminating the patient's dependence on conventional vision correction devices.

The CustomCornea algorithm led to a development of central islands in patients of LASIK shortly after its release. Central islands are elevated areas of the cornea due to a lack of the required laser energy for the procedure. Complications of central islands are usually immediately noticeable to the patient.

The algorithm is the source of the problem with the laser and the subject of the recall; the LADARVision 6000 as a whole is not believed to be a concern. The earlier model, the Alcon LADARVision 4000 laser, will not be affected by this recall at all.

Alcon voluntarily issued the recall of the CustomCornea algorithm when reports of the problem surfaced, and all patients of the LADARVision 6000 lasers are directed to contact Alcon toll free at 1-877-523-2784.

For more information on vision disorders, click here to go to the vision disorders section of The LASIK Directory.